GE Healthcare Biosciences: Medical Device Recall in 2018 - (Recall #: Z-0388-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.

Product Classification:

Class II

Date Initiated: September 10, 2018

Date Posted: November 28, 2018

Recall Number: Z-0388-2019

Event ID: 81454

Reason for Recall:

Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.

Status: Terminated

Product Quantity: 39

Code Information:

System Serial number OM20072 - OM40122

Distribution Pattern:

Worldwide - US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated